Jobs / United States / Astrazeneca Pharmaceuticals Lp
Senior Process Engineer, Cell Therapy Process Development
Astrazeneca Pharmaceuticals Lp · 🇺🇸 US – Santa Monica Colorado Avenue – CA
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 99 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Astrazeneca Pharmaceuticals Lp paid sponsored hires in similar roles12 certified filings for “Assoc. Princ. Scientist, Vector Engineering & Cell Line Dev.” (Molecular and Cellular Biologists) in MD: $103k–$158k, median $136k. Most were filed at wage level IV (33%) — 4 lottery entries, ≈61% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
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Sponsor Radar — Astrazeneca Pharmaceuticals Lp
The US Department of Labor certified 99 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Astrazeneca Pharmaceuticals Lp →
About the role
Position Summary We are seeking a highly motivated Senior Process Engineer to support cell therapy process characterization and commercialization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, PPQ readiness, BLA‑enabling studies, and technology transfer to different manufacturing sites. This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or automated equipment. The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness. Key Responsibilities Process development and characterization • Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies. • Drive implementation of closed-system operations and automation strategies to support scalability and compliance. • Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines. • Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums. • Support development and refinement of control strategies for cell therapy processes, including raw materials, and cell therapy process parameters. • Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes. • Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding. PPQ, Tech Transfer & Manufacturing Readiness • Contribute to PPQ planning, readiness, execution, and documentation for cell therapy processes. • Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch record. • Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required). • Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms. Regulatory Support • Contribute to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements. • Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing. Cross‑Functional Collaboration • Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end‑to‑end process alignment. • Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions. • Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes. Required Qualifications • Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 2+ years of industry experience; OR M.S. with 5+ years; OR B.S. with 7+ years of hands‑on industry experience. • Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreservation). • Demonstrated experience with GMP operations and late‑stage / commercial readiness. • Proven ability to analyze complex datasets, develop sound recommendations, and communicate clearly across levels • Experience with late‑stage